Apparatus for circulating a fluid within a body cavity



United States Patent [54] APPARATUS FOR CIRCULATING A FLUID WITHIN A BODY CAVITY 7 Claims, 6 Drawing Figs. [52] [1.5. CI 128/2, 128/241, 128/278 [51] Int. Cl. A61b 10/00 [50] Field ofSearch 128/2,

28, 240,241,227 (cursory), 228, 276, 278, 350

[56] References Cited UNITED STATES PATENTS 5,555 5/1843 Brailly 128/241 493,208 3/1893 Cruickshanlt 128/278UX. 750,276 1/1904 Gruss 123/240 883,583 3/1908 Stallsmith. 128/240 1,211,928 1/1917 Fisher 128/240 Primary Examiner-Richard A. Gaudet Assistant Examiner-Kyle L. Howell Attorney-Kane, Dalsimer, Kane, Sullivan and Kurucz ABSTRACT: A washing apparatus for irrigating a body cavity having an inlet tube which is open at both ends, and is adapted to have its forward end extend into a body cavity and its rear end connected to a source of washing fluid. Additionally, an outlet tube, which is open at both ends forms part of the apparatus. The inlet tube has its forward end adapted to extend into the body cavity with its rear end connected to a source of suction. A sealing member is positioned on the outlet and inlet tubes intermediate their ends and is adapted to seal the entrance to the body cavity. in operation, the source of suction provides a negative pressure to the body cavity and washing solution will pass through the inlet tube into the body cavity, accumulate cells and matter therefrom and pass through the outlet tube to a collection point.

Patented Sept. 8, 1970' R 3,527,203

Sheet 1 of 2 Q 2 h n 9 N "3 k INVENTOR v 154,4/1/0 '6. 6 641461. e

Patented Sept. 8, 1970 3,527,203

Sheet g of 2 Flat 3 INVENTOR L flA VO C, 6/64Vdff ATTORN Y5 APPARATUS FOR CIRCULATING A FLUID WITHIN A BODY CAVITY CROSS REFERENCE TO RELATED APPLICATIONS This application is a continuation-in-part of my previous application, Ser. No. 421,013 which was filed on December 24, 1964, now abandoned.

BACKGROUND OF THE INVENTION In the field of diagnosing various types of intrauterine cancer such as endometrial carcinoma in its early stages, the known methods for obtaining cells for diagnosis are not entirely satisfactory. There is a considerable need for an improved diagnostic device which will greatly improve the results.

As is well known in the art, with the aging population, the occurrence of endometrial carcinoma is rapidly approaching a one-toone ratio with the occurrence of carcinoma of the cervix. Endometrial carcinoma is in marked contrast to carcinoma of the cervix uteri with regard to early diagnosis. The recognition of cervical carcinoma is. an asymptomatic patient while the lesion is still intraepithelial is almost exclusively the result of advances in exfoliative cytology. Endometrial carcinoma, on the other hand, is rarely diagnosed in the asymtomatic patient and while it is frequently an indolent cancer of slow development, this biological feature is not reflected in survival statistics. Accordingly, if patient salvage is to be improved in cases of endometrial carcinoma, early diagnosis must be made more frequently than is possible with conventional or routine vaginal or cervical smears.

Routine vaginal and cervical smears are unsatisfactory for use in detecting endometrial carcinoma due to the fact that the endometrium does not exfoliate as readily as the cervix uteri or vagina. Accordingly, the number of cells reaching the vaginal pool is relatively small and the cells themselves frequently degenerate whereby the whole sample is heavily diluted by material from the cervix and vagina.

Various devices have been proposed to increase the efficiency of the test for endometrial carcinoma, such as the introduction of the sterile saline solution under pressure. This procedure has been found to be unsatisfactory due principally to the fact that diseased cells are often forced into other cavities, such as the Fallopian tubes thereby spreading the disease to other parts of the body. Additionally, rotary brush units have been employed, however, such units are unsatisfactory since they are difficult to sterilize and a possibility also exists that bristles will break off during the sampling process and thereby cause irritation and inflammation to the interior parts of the patient.

From the above, it is apparent that there is a need in the art for the provision of an intrauterine sampling device which will produce a sufficient and desirable amount of cell tissue for effective diagnosis. A device would be desirable which would avoid the problem of possible irritation of the inner parts of the patient and in particular the problems coexistent with many painful procedures of examination. In this manner, the necessity of an anesthetic is eliminated thereby allowing the doctor to simply obtain a sample in his office quickly and efficiently. Naturally as discussed above, it would also be advantageous to provide a sampling or washing device which would alleviate the danger of cells being washed to other parts of the body such as out the Fallopian tubes.

With the known types of sampling devices, utilization thereof is often very painful and requires an anesthetic to be used as well as other considerations for the comfort of the patient.

Another existent problem with devices being inserted into the uterus is the danger of the device being inserted too far so that it will pierce the uterus wall causing serious internal damage to the patient. Therefore, it would be advantageous to have an adjustable device whereby the distance it extends into the uterus can be regulated for a particular different size or shape ofa uterus.

It should also be kept in mind that although the washer has use in intrauterine diagnosis, particularly for the use of diagnosing endometrial carcinoma as described herein for exemplary purposes, it is also possible to adapt the device for many other uses such as in the lungs. In a similar manner, a sampling of tissue may be removed from the lungs for testing purposes. Furthermore, the washer may be used for radiation therapy in which radio opaque dye may be irrigated through the uterus. Also, this device as well may be used as a means of introducing therapeutic medicament in that the application of the fluid is localized.

SUMMARY OF THE INVENTION A washing apparatus for irrigating a body cavity consisting principally of an inlet tube, an outlet tube and a sealing member. The inlet tube is open at both ends and has its forward end adapted to extend into the body cavity when in position and its rear end is adapted for connection to a source of washing fluid. The outlet tube is also open at both ends and when in position has its forward end extending into the body cavity and its rear end is adapted for connection to a source of suction. The sealing member is positioned intermediate the ends and on the tubes and is adapted to seal the entrance to the body cavity. When suction is applied to the outlet tube a negative pressure is created in the body cavity and washing solution passes through the inlet tube into the body cavity, accumulates cells and matter therefrom and then exits through the outlet tube for collection.

It is a primary objective of this invention to alleviate the above mentioned problems by providing the washing apparatus for irrigating a body cavity which provides a negative pressure within the body cavity while collecting a highly desirable amount of cell tissue for analysis thereby minimizing the danger of malignant material entering the other body passages.

Another object is to provide an apparatus which may be easily and painlessly used in the doctors office without the necessity of administering an analgesic or anesthetic to the patient while still obtaining an improved sample of tissue for further diagnostic processes.

Still a further object of this invention is to provide an apparatus which is adjustable so as to properly fit the body cavity into which it is to be inserted in order to avoid the danger of damage such as piercing of the cavity wall.

Still another objective of this invention is to provide an apparatus which is economic to produce, efficient to use, and which may be disposed of after single use.

Still a further object of this invention is to provide an ap paratus which, in addition to matter collected by the washing action thereof, will collect additional tissue by a scraping action as the device is inserted or removed from the body cavity.

Other objects and advantages will become apparent from the following detailed description which is to be taken in conjunction with the accompanying drawing illustrating a preferred embodiment of this invention.

A BRIEF DESCRIPTION OF THE DRAWING With the foregoing in mind, reference is made to the accompanying drawing in which:

FIG. 1 is a side view of a washing apparatus embodying this invention;

FIG. 2 is a schematic view thereof showing the device in position within a uterus and being connected to a suction source and a source of washing solution;

FIG. 3 is a fragmentary sectional side view of the forward portion of a washing apparatus embodying this invention;

FIG. 4 is a fragmentary side elevation view of the forward portion of the outlet tube part of a washing apparatus embodying this invention;

FIG. 5 is a sectional end view of the forward portion of a washing apparatus embodying this invention taken along the plane of line 5-5 of FIG. 3; and

FIG. 6 is a sectional end view thereof taken along the plane ofline 66 of FIG. 3.

DESCRIPTION OF THE PREFERRED EMBODIMENT As stated above, the washing apparatus of this invention is useful for many applications, however, for descriptive purposes, the device will be applied as an intrauterine washing device in the following discussion.

As shown in FIG. 1, the intrauterine washing apparatus 20 is comprised basically of three main parts. There is an inlet tube 21, an outlet tube 22, and a sealing member 23.

Inlet tube 21 has an adapter 24 at its rear end which may be connected to a source of washing solution. At the other end of inlet tube 21 is a series of aligned apertures 25 along the end portion surface thereof and an opening 26 at the forward end. The outlet tube 22 has an adapter 27 at its rear end for connection to a source of suction. At its forward end it also has a series of apertures 28 adjacent the end and an opening 29 at its end.

Inlet tube 21, outlet tube 22, and adapters 24 and 27 are generally constructed of a low cost plastic material however, other materials well known in the art having similar properties will work satisfactorily. The forward portions of inlet tube 21 and outlet tube 22 are fastened in a permanent connection by any common well known non-toxic adhesive means. Adapters 24 and 27 are similarly fastened to the rear end of tubes 21 and 22. It should be noted that, alternatively, inlet tube 21 and outlet tube 22 may consist of a body of one-piece plastic construction with two separate passageways therein to form tubes 21 and 22.

Turning to FIGS. 3-6, the forward portions of inlet tubes 21 and outlet tube 22 can be observed in greater detail. To obtain the desirable negative pressure within the uterus when the washer 20 is inserted therein, it will be observed that outlet tube 22 is of a considerably larger diameter than inlet tube 21. Furthermore, there are a larger number of apertures 28 in outlet tube 22 than there are apertures 25 in inlet tube 21. In addition, apertures 28 are also of a considerably larger diameter than apertures 25. This aids in providing a negative pressure within the uterus and helps in minimizing the danger of too great an amount of fluid being within the uterus during the washing operation.

It should also be noted that there are three apertures 30 which extend through the adjoining surfaces of inlet tube 21 and outlet tube 22 which thereby communicate the passages through tubes 21 and 22. Holes 30 are valuable in initiating the washing action when the device has been inserted into the uterus by serving to aid in providing a priming action.

Turning to the adjustable stop 23, it is generally constructed of a rubber material although other well known materials would be adequate, and is acorn in shape so as to facilitate its insertion into the opening to the uterus and the forming of a proper seal therein. Sealing member 23 has an opening therein corresponding to the combined configuration of the cross section of inlet tubes 21 and 22 as seen in FIG. 6 The size ofthe opening to receive tubes 21 and 22 is of such a dimension that a tight fitting engagement will be initiated between sealing member 23 and tubes 21 and 22 when it is positioned thereon. However, the engagement is such that, with an application of sufficient force, sealing member 23 may be slidably moved along the adjoining surfaces of tubes 21 and 22 so that washer 20 may be adjusted in size to correspond to the particular size and shape of the uterus being examined.

In operation, as shown in FIG. 2, the washer is inserted into the opening in the uterus until sealing member 23 enters into sealing engagement with the lower portion thereof. By prior examination the proper length of the forward portion of tubes 21 and 22 can be determined and the device properly adjusted so that it will not extend too far into the uterus and pierce the rear or upper walls thereof causing internal damage to the patient.

Generally, the particular configuration and shape of the uterus will cause it to have its lower portion positioned adjacent to the openings in inlet and outlet tubes 21 and 22 when the washer 20 is properly positioned. As shown, adapter 24 is positioned into a beaker of saline solution 32. Beaker 32 is merely exemplary as many types of devices for holding the saline solution. Likewise, adapter 27 is connected to the forward end of a syringe 33 which will provide a source of vacuum when plunger 34 is drawn from barrel 35. Naturally, other types of vacuum producing devices well known in the art will work adequately in place of syringe 33.

As plunger 34 is removed from syringe barrel 35, negative pressure will be created within uterus 36 and saline solution will flow through inlet 21 and will exit through apertures 25 in the forward portion thereof. It is generally believed that the flow of the solution will be at substantially right angles to the longitudinal axis of inlet tube 21 as it exits therefrom so that it will come in contact with the adjacent wall of uterus 36 and gather tissue therefrom. A small amount of fluid will also exit from end opening 26 of inlet tube 21.

It should also be noted that, as discussed above, a priming action also occurs because of fluid flowing through apertures 30 into the adjacent larger diameter outlet tube. This initiates the proper flow pattern and turbulence and the fluid within the uterus will generally circulate in the lower portion thereof and the majority of it will enter larger apertures 28 in the outlet tube carrying with it a good sampling of tissue for diagnosis. A small portion of the fluid within the uterus will also exit through opening 29 in the end of outlet tube 22. The fluid and tissue combination will exit through outlet tube 22 into syringe 33 for collection and later testing.

The fact that outlet tube 22 is of a much larger diameter than inlet tube 21 and that holes 28 are ofa larger number and a larger diameter than holes 25, facilitates the provision of negative pressure within the uterus so that the fluid may exit more freely than it enters the uterus. In this manner, the uterus does not fill up with fluid which could cause some of the fluid and possibly undesirable tissue to enter Fallopian tubes 31. Furthermore, in some instances, the negative pressure within the uterus may be great enough so as to cause the Fallopian tubes to be squeezed together and thereby closing off the entrance thereto which would of course render it substantially impossible for any malignant tissue to enter the Fallopian tubes 31.

Apertures 28 and 25 have roughened edges thereon which aids in enabling tissue to collect at the entrances to these holes thereby providing a better sample when the washer is inserted or removed. Furthermore, as the washer is removed these roughened edges will perform a scraping operation to remove additional tissue from the adjacent side walls of the uterus and entrance thereto which also aids in obtaining the most desirable sample for testing. The cells collected by all of the above discussed means when using washer 20 provide a very effective sampling for diagnostic purposes. Therefore, the results obtained by using the washer 20 have been much improved over any other known methods.

It should also be kept in mind that the use of washing apparatus 20 causes a minimal amount of discomfort to the patient. There is relatively no accompanying pain during the sampling operation. Therefore, there is no need for any anesthetic to be used and the device may be used right in the individual doctors office thereby facilitating the rapid and early detection of any malignancy in the uterus.

When the doctor is to use the device in his office, in order to obtain a proper sample, he begins by the normal operations of inserting an unlubricated speculum into the vagina and doing Pap smear tests of the cervix in a routine manner. He then removes the speculum and does a bimanual examination while noting the sides and position of the uterus. He then re-introduces the speculum and cleans the cervix with a cleansing solution. He sounds the uterus to determine the adjustment necessary for the sealing member further probing the entire uterine cavity with the sound sufficiently to aid in the loosening of cells for the later washing operation. He then adjusts the sealing member 23 of the washer 20 to provide the proper length of the tubes to extend into the uterus. The washer is then extended into the patient until sealing member 23 forms a seal in the mouth of the cervix. lnlet tube 21 is then inserted into the receptacle holding the sterile saline solution and a syringe or similar device is attached to outlet tube 22 for providing the proper vacuum. The plunger is then withdrawn to draw a desired amount of solution into the syringe. This specimen is then expelled from the syringe into a standard centrifuge tube or similar device for processing in the laboratory. The washer 20 may then be disposed of or it may be resterilized for further use.

Thus the aforementioned objects and advantages are most effectively attained. Although a preferred embodiment of this invention has been disclosed in detail herein, it should be understood that this invention is in no sense limited thereby, and its scope is to be determined by that of the appended claims.

Iclaim:

1. A washing apparatus for collecting cellular material from the inner walls of a body cavity upon partial insertion into the body cavity without discomfort to the patient comprising:

an inlet tube having an open forward end and an open rear end and having its forward end adapted to be extended into the body cavity and its rear end adapted for connection to a source of washing fluid;

an outlet tube having an open forward end and an open rear end and having its forward end adapted to be extended into the body cavity and its rear end being adapted for connection to a source of suction, the forward end of each tube being connected to one another in side-by-side relationship;

a sealing member positioned on said outlet and inlet tubes intermediate the ends thereof in sealing engagement therewith and being adapted to seal the entrance to the body cavity when the forward end of said tubes is extended into the body cavity; and

the inlet and outlet tubes having a plurality of apertures spaced longitudinally along the forward end portions thereof, at least one ofthe apertures in the forward end of each tube communicating with one another, the area of the apertures in the outlet tube being larger than that of the inlet tube, the apertures being arranged so that a number of the apertures of the inlet tube are exposed to the walls of the body cavity and when said tubes are positioned within the body cavity and connected to a source of suction and a source of washing fluid and said sealing members seal the entrance to said body cavity, the suction provided by said suction source will provide negative pressure within said body cavity and washing fluid from the fluid source will be drawn through the inlet tube and out of the apertures in the forward end thereof in the form ofa spray which will contact a substantial portion of the walls of the body cavity, accumulate cells and matter therefrom and will be drawn from the body cavity by the suction force into the apertures in the outlet tube to pass through said outlet tube for collection and examination, and the negative pressure within said body .cavity will maintain the fluid in said cavity to a minimum amount at any given time to thereby alleviate the danger of passage of the fluid under positive pressure and containing collected matter to other portions of the body before entering the outlet tube.

2. The invention in accordance with claim 1 wherein a suction source is connected to the open rear end of said outlet tube whereby the flow from said fluid source through said inlet tube, body cavity, and outlet tube is continuous as suction is continuously applied by said suction source when said apparatus is connected to a fluid source, a suction source and properly positioned with respect to the body cavity.

3. The invention in accordance with claim 1 wherein said inlet tube is positioned adjacent to the wall of said outlet tube with a substantial portion of the apertures in the inlet tube being directed toward the wall of the body cavity in which the apparatus may be placed so that the fluid being drawn from said inlet tube may directly contact the walls of the body cavity without interference from said outlet tube. l

4. The invention in accordance with claim 1 wherein the exterior edges of said apertures are roughened to aid in the collection of tissue during the washing period and while the apparatus is being inserted and removed from the body cavity, the sealing member being acorn shaped to facilitate the provision of a proper seal at the entrance of said body cavity, and said sealing member being slidably mounted on the tubes to permit adjustment thereof relative to the ends of the tube. V

5. A washing apparatus for circulating a fluid within a uterus for collecting cellular material from the inner walls thereof for diagnostic purposes comprising:

a pair of conduits mounted in position for one end portion of one conduit to extend adjacent and in essentially sideby-side connected relationship to one end portion of the other conduit;

said one end portion of each of said conduits being of a predetermined size and length and adapted to be inserted into a uterus and each having a plurality of longitudinally spaced openings provided in said one end portion of each of said conduits disposed to communicate said conduits with a uterus, the area of the openings in said other conduit being larger than that of said one conduit;

means to connect the other end of said one conduit to a receptacle for supplying the fluid to be circulated within the uterus for washing the inner walls thereof;

sealing means associated with said one conduit and said other conduit in position to engage the cervix of a uterus after insertion of said one conduit and said other conduit into the uterus to define a seal between the cervix and said conduits to prevent the egress of fluid between the cervix and said conduits; and

means to create a negative pressure within the outer end of said other conduit and adjacent thereto relative to the pressure within said one conduit whereby the fluid flows freely from said one conduit and into said other conduit with the suction provided by said negative pressure means drawing washing fluid from the receptacle through said one conduit and out of the openings in the forward end thereof in the form of a spray which will contact a substantial portion of the walls of the uterus, accumulate cells and matter therefrom and the cellular material laden fluid will be drawn from the uterus by the suction means into the other conduit to pass through said other conduit for collection and then examination, and the negative pressure within the uterus maintaining the fluid in said uterus to a minimum amount at any given time to thereby alleviate the danger of passage of the fluid under positive pressure and fluid containing collected matter to other portions of the body before entering the other conduit.

6. A tip for a washing apparatus utilized in the collection of cellular material from the inner walls of a body cavity upon insertion of the tip into the body cavity without undue discomfort to the patient, the washing apparatus including an inlet tube open at both ends and adapted to be connected at its rear end to a fluid source, an outlet tube open at both ends and adapted to be connected at its rear end to a source of suction, the forward ends of each tube being connected to one another in side-by-side relationship, the inlet and outlet tubes having a plurality of apertures spaced longitudinally along the forward end portions thereof, at least one of the apertures in the forward end of each tube communicating directly with one another, the area of the apertures in the outlet tube being larger than that of the inlet tube and a number of the apertures of the inlet tube being exposed to the walls of the body cavity, said tip comprising:

a sealing member on said tubes in sealing engagement therewith and adapted to seal the entrance of the body cavity upon insertion of said tip into said body cavity; and

the apertures in the outer surface of the tubes being arranged so that when said tubes are connected to said fluid and suction sources, and said tip is sealingly positioned within said body cavity, the suction provided by said suction source will provide negative pressure within said body cavity and washing fluid from the fluid source will be drawn through the inlet tube and out of the apertures in the forward end thereof in the form of a spray which will contact a substantial portion of the walls of the body 1 cavity, accumulate cells and matter therefrom and will be 7. The invention in accordance with claim 5 wherein means for sealing the entrance to the body cavity is positioned on said tip elements.

drawn from the body cavity by the suction force into the 

